Medicine Quality Alert: Class II Medicine Recall of Phenytoin 100mg Tablets Batch Number 0724016
Biodeal Laboratories Ltd has initiated a voluntary recall of Phenytoin 100mg tablets, Batch Number 0724016
From: Pharmacy and Poisons Board
Date of Recall Initiation: 15th July 2025
Recall Reference Number: REC/2025/022
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Biodeal Laboratories Ltd, Kenya
Product name: Phenytoin 100mg tablets
Active Pharmaceutical Ingredient: Phenytoin 100mg tablets
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
0724016 | 07/2024 | 06/2027 | 100’s |
Brief description of the problem
The product is being recalled due to failure to comply with the specifications on appearance, as the product changed color.
Action for healthcare professionals
Stop supplying Phenytoin 100mg tablet (Phenytoin 100mg) BN 0724016 immediately. Quarantine all remaining stock and await contact from Biodeal Laboratories Ltd, Kenya, to arrange the return.
Action for patients and carers
Patients currently prescribed should contact their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.
Further Information
For inquiries about consignments of the impacted batch, please contact Biodeal Laboratories Ltd, Kenya, at regulatoryaffairs@biodealkenya.com, chriskibathi@biodealkenya.com, freshia@biodealkenya.com, or telephone via +254 722 214178
Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
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Medicine Quality Alert: Class II Medicine Recall of Phenytoin 100mg Tablets Batch Number 0724016